[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Washington D.C. Veterans Affairs Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":192},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,51,83,107,137,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100563027","phase-2-castrate-resistant-prostate-cancer-enhertu-therapy-100563027",false,"NCT06610825","Castrate Resistant Prostate Cancer Enhertu Therapy","A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fam-Trastuzumab Deruxtecan-Nxki (T-DXd) as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma","CaRPET","Inclusion Criteria:\n\n* Pathologically confirmed adenocarcinoma of the prostate\n* Diagnosis of mCRPC\n* Documented progression on androgen deprivation and novel hormonal agents, with or without progression on taxane containing regimen\n* Ongoing ADT to maintain serum testosterone levels below 50 ng\u002FdL\n* Formalin fixed paraffin embedded tumor tissue for HER2 immunohistochemistry\n* Life expectancy 6 months\n* ECOG 0 or 1\n* LVEF at least 50%\n* Adequate Blood Clotting function\n* Adequate Organ and Bone Marrow function\n* Adequate Renal function\n* Adequate Hepatic function\n\nExclusion Criteria:\n\n* History of interstitial lung disease or pneumonitis requiring steroids\n* Significant coronary vascular disease\n* Previous exposure to HER2 targeted therapy","MALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.",[27,28,29],"Prostate Cancer Metastatic","Prostate Cancer","CRPC",[31,32,33,34,35,36,37],"prostate cancer","metastatic prostate cancer","Enhertu","HER2 positive","Trastuzumab deruxtecan","crpc","phase 2","RECRUITING","2026-04-06",{"date":41,"type":42},"2026-04-13","ACTUAL",{"date":44,"type":42},"2025-03-05",{"date":46,"type":21},"2028-10",{"name":48,"class":49},"Washington D.C. Veterans Affairs Medical Center","FED",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":50},"100604913","phase-4-role-of-finerenone-in-african-american-veterans-with-diabetic-kidney-disease-100604913","NCT07155694","Role of Finerenone in African American Veterans With Diabetic Kidney Disease","Inclusion Criteria:\n\n1. Diagnosis of type 2 diabetes (HbA1C at or above 6.5%, or fasting blood glucose of more than 125 or random\u002F post prandial blood glucose of more than 199mg%)\n2. African American veterans\n3. Age 20-90 years\n4. eGFR ≥25-89 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI equation)\n5. Albuminuria of 30 mg\u002Fg or higher\n6. BMI=18-39.9\n7. Blood pressure controlled to ≤140\u002F90\n8. Ability to provide informed consent before any trial related activities are conducted.\n\nExclusion Criteria\n\n1. If a patient is on statin, need to be on a stable dose for a month.\n2. Biopsy proven diagnosis of glomerular disease\u002Fglomerulonephritis\n3. Active smokers,\n4. Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)\n5. Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure\n6. Hypersensitivity to empagliflozin or finerenone\n7. Patients on dialysis\n8. eGFR less than 25 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI equation\n9. Planned surgery or planned hospital admission within 5 months of participation in the study\n10. At the discretion of PI to ensure health, safety, and well-being of the veteran, participation in this study may be stopped (please see withdrawal criteria)\n11. Patients with prior history of diagnosis of heart failure with documented EF of less than 50.\n12. Proven diagnosis of Polycystic Kidney Disease.","ALL","20 Years","90 Years",{"count":61,"type":21},30,[63],"PHASE4","Primary Objectives: To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine from African American Veterans with albuminuric stage 2 and 3 chronic diabetic kidney disease (DKD), using Empagliflozin or Finerenone or combination therapy.\n\nSecondary Objectives: (1). Correlate changes in exosome-based PSP with standardized biomarkers of kidney injury including urine albumin\u002Fcreatinine ratio (ACR) and estimated GFR. (2) with systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12), hs-CRP and (3) arterial stiffness measures and with (4) APOL1 mRNA expression levels in peripheral blood derived mononuclear cells (MNC).",[66],"Diabetic Kidney Disease",[68,69,70,71,72,66,73],"Empagliflozin","Finerenone","Empagliflozin and Finerenone combination","Podocyte Injury","Chronic Kidney Disease","Diabetes Mellitus","NOT_YET_RECRUITING","2025-08-26",{"date":77,"type":42},"2025-09-04",{"date":79,"type":21},"2025-09",{"date":81,"type":21},"2027-08",{"name":48,"class":49},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":57,"minAge":91,"maxAge":59,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":50},"100524545","phase-4-effect-of-empagliflozin-on-podocyte-specific-proteins-in-african-american-veterans-with-ndkd-100524545","NCT06110130","Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD","Effect of Empagliflozin on Podocyte Specific Proteins (Injury Markers) in African American Veterans With Non-Diabetic Chronic Kidney Disease","EMPA CKD","Inclusion Criteria:\n\n1. African American veterans\n2. Age \\> 18 years\n3. eGFR ≥20-59 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI equation, with or without any degree of albuminuria OR\n4. eGFR 60-89, with UACR of ≥30mg\u002Fg\n5. BMI = 18-39.9\n6. Blood pressure controlled to ≤140\u002F90\n7. Subjects without diabetes: will be screened using routine glucose level test: of less than 126 fasting glucose or less than 200mg\u002Fdl of random or post glucose blood glucose level in standard of care laboratory workup.\n8. Ability to provide informed consent before any trial related activities are conducted.\n\nExclusion Criteria:\n\n1. Diagnosed with Type 1 or Type 2 Diabetes Mellitus\n2. Any prescribed diabetes medication for patients, such as GLP1RA, SGLT2is, and sulphonylureas\n3. If a patient is on statin, need to be on a stable dose for a month.\n4. Biopsy proven diagnosis of glomerular disease\u002Fglomerulonephritis\n5. Active smokers,\n6. Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)\n7. Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure\n8. Hypersensitivity to empagliflozin or any of the excipients in Jardiance, reactions such as angioedema\n9. Patients on dialysis\n10. eGFR less than 20 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI equation\n11. Planned surgery or planned hospital admission within 5 months of participation in the study\n12. At the discretion of PI to ensure health, safety, and well-being of the veteran, participation in this study may be stopped (please see withdrawal criteria)\n13. Patients with prior history of diagnosis of heart failure with documented EF of less than 50.\n14. Proven diagnosis of Polycystic Kidney Disease.","19 Years",{"count":20,"type":21},[63],"Primary Objective:To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease(NDKD), on empagliflozin therapy.\n\nPrimary Endpoint: Assess the effect of Empagliflozin on podocyte-specific proteins in exosomes isolated from subjects' urine, such as nephrin, podocalyxin and Wilms'Tumor (WT-1) protein.\n\nSecondary Objective:\n\n1. Correlate changes in exosome-based podocyte specific proteins with standardized biomarkers of kidney injury including urine albumin\u002Fcreatinine ratio (ACR) and estimated GFR.\n2. Correlate systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12) , hs-CRP and arterial stiffness measures with urine exosome-based podocyte protein estimation.\n3. Correlate urine podocyte-specific protein markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC)",[96],"Chronic Kidney Diseases",[98],"Non-diabetic","2025-07-16",{"date":101,"type":42},"2025-07-20",{"date":103,"type":42},"2024-02-02",{"date":105,"type":21},"2028-12-01",{"name":48,"class":49},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":57,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":50},"100585733","low-intensity-focused-ultrasound-for-chronic-pain-high-resolution-targeting-of-the-human-insula-100585733","NCT06906211","Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula","LIFU_Pain","Inclusion Criteria:\n\n* Veterans aged 21 to 75 with Chronic Back Pain (CBP).\n* CBP duration daily for last 3 months or half of days for last 6 months\n* Endorse pain rating of 4\u002F10 BPI-SF\n* Evidence of widespread pain symptoms as determined by report of CBP and pain in a contralateral limb (pain in the upper, lower, left or right side of the body) in fewer than 11 sites. Upper body sites include hand, wrist, elbow or shoulder. Lower sites include hip, knee, ankle or foot.\n\nExclusion Criteria:\n\n* Surgery recommended as primary treatment intervention for CBP\n* Current diagnosis of fibromyalgia\n* Current substance use disorder other than nicotine.\n* Psychiatric disorder and not on a stable pharmacologic regimen for ≥ 4 weeks prior to screening\n* Opiate use daily\n* Currently pregnant or breast feeding.\n* Unable to understand the consent form.\n* History of head injury with loss of consciousness for more than 5 minutes, seizures, history of stroke, brain surgery, brain tumor, multiple sclerosis.\n* History of metastatic cancer, rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, or polymyositis\n* Unintended weight loss of 20 pounds or more in the last year\n* Cauda equina syndrome\n* Ferromagnetic implants or other contraindications for MRI\n* Uncompensated congestive heart failure, unstable angina, poorly controlled arrhythmia, active systemic infection end stage renal disease.","21 Years","75 Years",{"count":117,"type":21},66,[119],"NA","In this study, the research team will use low-intensity focused ultrasound (LIFU) to temporarily change brain activity in a brain region that is known to be involved in chronic pain. Through this, the research team hopes to learn about how the brain area works in response to pain. There are main questions this study aims to answer:\n\n* The effect of LIFU to inhibit the posterior region of the insula (PI) compared to sham stimulation in individuals with chronic back pain (CBP) and widespread pain symptoms.\n* The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of the Neurologic Pain Signature (NPS) in response to evoked thermal pain.\n* The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of Tonic Pain Signature in response to tonic pain.",[122,123],"Chronic Back Pain","Chronic Pain (Back \u002F Neck)",[125,126,127,128],"low intensity focused ultrasound","chronic back pain","chronic pain","functional magnetic resonance imaging","2025-03-25",{"date":131,"type":42},"2025-04-02",{"date":133,"type":42},"2025-01-15",{"date":135,"type":21},"2028-01-26",{"name":48,"class":49},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":145,"sex":57,"minAge":18,"maxAge":115,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":50},"100550902","focused-ultrasound-for-the-complex-patient-100550902","NCT06453109","Focused Ultrasound for the Complex Patient","Towards Treatment of the Complex Patient: Investigations of Low-intensity Focused Ultrasound","LIFU","Inclusion Criteria:\n\n1. Males and females aged 18-75 years\n2. Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months.\n3. Have evidence of central sensitization (CS) as measured by the Widespread Pain\u002FSymptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9.\n4. Participants must rate pain intensity at 4\u002F10 or greater on the Brief Pain Inventory-Short Form (BPI-SF)\n5. Meet the DSM-5 criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.\n6. Be in treatment for OUD including buprenorphine or methadone.\n7. Meet the DSM-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5).\n\nExclusion Criteria:\n\n1. Evidence of neuropathic pain\n2. Current DSM-5 substance use disorder other than OUD, tobacco use disorder\n3. Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder\n4. Pregnant or breastfeeding\n5. Daily use of benzodiazepines or opiates (other than buprenorphine or methadone)\n6. History of seizures, neurologic disorders, including cerebrovascular disease, history of stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases. They will not have history of metastasizing cancers, inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis, unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome.\n7. Ferromagnetic implants or other contraindications for MRI\n8. Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active systemic infection end stage renal disease.",true,{"count":147,"type":21},25,[119],"The goal of this clinical trial is to to inhibit the anterior insula (AI) with low intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain processing, anxiety, and opiate cue-induced craving. The main question\\[s\\] it aims to answer are:\n\n* the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder (OUD), anxiety, and chronic back pain\n* the effects of LIFU vs sham on measures of pain processing, anxiety symptoms, and opiate cue-induced craving\n\nParticipants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.",[151,122,152],"Opioid Use Disorder","Anxiety",[154,155,156,157,158,126,159,160,161,125,162],"anxiety disorders","oud","opiate use disorder","opioid","back pain","opioid use","opioid abuse","opioid disorder","transcranial ultrasound","2024-11-15",{"date":165,"type":42},"2024-11-20",{"date":167,"type":42},"2024-04-29",{"date":169,"type":21},"2025-09-30",{"name":48,"class":49},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":115,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":50},"100547215","low-intensity-focused-ultrasound-for-tobacco-use-disorder-high-resolution-targeting-of-the-human-insula-100547215","NCT06405074","Low Intensity Focused Ultrasound for Tobacco Use Disorder: High Resolution Targeting of the Human Insula","LIFU_TUD","Inclusion Criteria:\n\n1. Male and female veterans aged 18-75 years\n2. Meet the Diagnostic and Statistical Manual, Fifth edition (DSM-5) criteria for current TUD (moderate to severe) as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.\n3. Currently smoking \\> 10 cigarettes per day with no period of abstinence \\> 3 months in the last year\n4. Current use of tobacco in last year is limited to cigarettes\n5. Currently in Contemplation Stage of motivation for behavior change with respect to smoking as assessed by the University of Rhode Island Change Assessment Scale\n\nExclusion Criteria:\n\n1. Not under current treatment for smoking cessation.\n2. No history of head injury, seizures, neurologic disorders including cerebrovascular disease, multiple sclerosis, or neurodegenerative diseases or major medical illness\n3. Current substance use disorder for a psychoactive substance (except nicotine)\n4. DSM-5 psychiatric disorder requiring current treatment\n5. Ferromagnetic implants or other contraindications for MRI\n6. Taking any psychotropic medication such as antidepressants, anxiolytics and antipsychotics.\n7. any medication other than psychotropic medications that is known to cross the blood brain barrier and achieve brain penetrance such that it will alter BOLD signal or lower seizure threshold, such as antibiotics, antihistamines or muscle relaxants.\n8. currently pregnant or breast feeding",{"count":179,"type":21},44,[119],"The goal of this clinical trial is to to inhibit the dorsal anterior insula (dAI) with low intensity focused ultrasound (LIFU) to determine the causal role for the dAI in smoking cue induced craving in individuals with tobacco use disorder (TUD); smoking cue induced craving is a clinically important behavior which has been associated with the severity of nicotine addiction. The main question\\[s\\] it aims to answer are:\n\n* the safety and tolerability of dAI LIFU compared to sham stimulation in individuals with TUD\n* the effects of LIFU vs sham to left dAI functional magnetic resonance imaging (fMRI) BOLD activity and craving in response to smoking cue exposure.\n\nParticipants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.\n\nParticipants will undergo functional magnetic resonance imaging where we will measure the effect of LIFU vs sham on 1) dAI blood-oxygen-level-dependent (BOLD) activation in response to smoking (compared to neutral) cue exposure and 2) cue-induced craving in individuals with TUD. Each participant will receive LIFU and sham stimulation.",[183],"Tobacco Use Disorder",[125,128,185],"insula",{"date":165,"type":42},{"date":188,"type":42},"2022-04-01",{"date":190,"type":21},"2026-03-31",{"name":48,"class":49},""]